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Page 1: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

Last Updated 12.11.2017

V. Communicable Disease Reporting & Law

Page 2: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within
Page 3: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

ATTENTION HEALTH CARE PROVIDERS:Please report relevant clinical findings about this

disease event to the local health department.

North Carolina Department of Health and Human ServicesDivision of Public Health • Epidemiology Section

Communicable Disease Branch

Birthdate (mm/dd/yyyy) / /SSN

Patient’s Last Name First Middle Suffix Maiden/Other Alias

NC Electronic Disease Surveillance System NC EDSS EVENT ID# ____________________

Instructions for completing the Communicable Disease Report Form can be found in the NC Public Health Communicable Disease Manual online at: www.epi.state.nc.us/epi/gcdc/manual/toc.html.

Questions? Concerns? Contact the NC EDSS Helpdesk:Phone: ......................................................(919) 715-5548Toll Free: ...................................................(877) 625-9259Email: [email protected]

NC EDSSLAB RESULTS

Verify if lab results for this event are in NC EDSS. If not present, enter results.

Patient’s Last Name First Middle Suffix Maiden/Other Alias

Birthdate (mm/dd/yyyy)

Age Age Type

Years

Months

Weeks

Days

Race (check all that apply):

White

Black/African American

American Indian/Alaska Native

Native Hawaiian or Pacific Islander

Asian

Other

Unknown

Ethnic Origin

Hispanic

Non-Hispanic

Sex

M F Trans.

Patient IdentifierParent or Guardian (of minors)

Patient is associated with (check all that apply):

Child Care (child, household contact, or worker in child care)

School (student or worker)

College/University (student or worker)

Food Service (food worker)

Health Care (health care worker)

Correctional Facility (inmate or worker)

Long Term Care Facility (resident or worker)

Military (active military, dependent, or recent retiree)

Travel (outside continental United States in last 30 days)

Is the patient part of an outbreak of this disease? Yes No

Outbreak setting: Restaurant/Retail (name): ___________________________________________________

Household (specify index case): _______________________________________________

Child Care (name): _________________________________________________________

Other (specify): ___________________________________________________________

Community (specify index case): ______________________________________________

In what geographic location was the patient MOST LIKELY exposed? In patient’s county of residence

Outside county, but within NC - County: ________________________

Out of state - State/Territory: _________________________________

Out of USA - Country: _______________________________________

Unknown

Did patient die from

this disease?

Yes No

Is the patient

pregnant?

Yes No

Was patient hospitalized for

this disease? (>24 hours)

Yes No

Initial Date of Report to Public Health:____/____/_______

Initial Source of Report to Public Health:

Health Care Provider (specify):

Hospital Private clinic/practice Health Department Correctional facility

Laboratory Other

Specimen Date

Specimen # Specimen Source

Type of Test Test Result(s)

Description (comments) Result Date Lab Name—City/State

/ / / // / / // / / /

Is/was patient symptomatic for this disease? .................................. Y N UIf yes, symptom onset date (mm/dd/yyyy): __/__/____SPECIFY SYMPTOMS:

If a sexually transmitted disease, give specific treatment details:

1. Date patient treated:(mm/dd/yyyy) ____________

Medication ______________________________

Dosage _________________________________

Duration ________________________________

SSN

DHHS 2124 (Revised January 2009) EPIDEMIOLOGY

Patient’s Street Address City State ZIP County Phone

(_____) _____-_______

Confidential Communicable Disease Report—Part 1

CLINICAL INFORMATION

DIAGNOSTIC TESTING

NC DISEASE CODE(see reverse side for code)

LOCAL HEALTH DEPARTMENT USE ONLY

Health Care Provider for this disease (if not reporting physician):

____________________________________________________________

Contact Person/Title: ___________________________________________

Phone: (______) ______– ________ Fax: (______) ______– __________

Reporting Physician/Practice:

____________________________________________________________

Contact Person/Title: ___________________________________________

Phone: (_____) _____–_________ Fax:(_____) _____– _______________

2. Date patient treated:(mm/dd/yyyy) ____________

Medication ______________________________

Dosage _________________________________

Duration ________________________________

Provide lab information below OR attach a copy of lab results.

Page 4: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

Diseases and Conditions Reportable in North Carolina

DISEASE/CONDITION NC DISEASE CODEA-G

AnthrAx .............................................................................................3Botulism, foodBorne ................................................................10Botulism, intestinAl (infAnt) ................................................ 110Botulism, wound ........................................................................ 111Campylobacter infection ......................................................................50Chancroid ..........................................................................................100Cholera ..................................................................................................6Cryptosporidiosis .................................................................................56Cyclosporiasis .....................................................................................63Diphtheria ..............................................................................................8E. coli infection, shiga toxin-producing ................................................53Foodborne disease: Clostridium perfringens ....................................... 11Foodborne: staphylococcal..................................................................12Foodborne disease: other/unknown ....................................................13Foodborne poisoning: ciguatera ........................................................130Foodborne poisoning: mushroom ......................................................131Foodborne poisoning: scombroid fish................................................132Gonorrhea .........................................................................................300Granuloma inguinale .........................................................................500

H-NHaemophilus influenzae,

invasive disease ................................................................................23Hemolytic-uremic syndrome (HUS) .....................................................59hemorrhAgic fever virusinfection .........................................................................................68Hepatitis A............................................................................................14Hepatitis B, acute ................................................................................15HIV/AIDS

HIV...................................................................................................900AIDS ................................................................................................950

Influenza pediatric death (<18 years) ..................................................73Listeriosis.............................................................................................64Measles (rubeola) ................................................................................22Meningococcal disease, invasive ........................................................27Monkeypox ..........................................................................................72novel influenzA virus infection ...........................................75

O-UOphthalmia neonatorum ....................................................................345Pertussis (Whooping Cough)...............................................................47 PlAgue ..............................................................................................29Poliomyelitis, paralytic .........................................................................30Rabies, human ....................................................................................33Rubella ................................................................................................36Salmonellosis ......................................................................................38S. aureus with reduced susceptibility to vancomycin ..........................74SARS (coronavirus infection) ..............................................................71Shigellosis ...........................................................................................39smAllPox .........................................................................................69Syphilis

primary.............................................................................................710secondary ........................................................................................720early latent .......................................................................................730latent, unknown duration .................................................................740late latent .........................................................................................745late with symptoms ..........................................................................750neurosyphilis....................................................................................760congenital ........................................................................................790

Tuberculosis ....................................................................................... TBtulAremiA .......................................................................................43Typhoid Fever, acute ...........................................................................44

V-ZVaccinia ...............................................................................................70Vibrio infection, other than cholera & vulnificus ...................................55Vibrio vulnificus ....................................................................................54

DISEASE/CONDITION NC DISEASE CODEA-G

Brucellosis .............................................................................................5Chlamydial infection—laboratory confirmed .....................................200Creutzfeldt-Jakob Disease ..................................................................66Dengue ..................................................................................................7Ehrlichiosis, HGA (human granulocytic anaplasmosis) .....................571Ehrlichiosis, HME (human monocytic or e. chaffeensis) ...................572Ehrlichiosis, unspecified ....................................................................573Encephalitis, arboviral, WNV ...............................................................95Encephalitis, arboviral, LAC ................................................................96Encephalitis, arboviral, EEE ................................................................97Encephalitis, arboviral, other ...............................................................98

H-NHantavirus infection .............................................................................67Hepatitis B, carriage .......................................................................... 115Hepatitis B, perinatally acquired ........................................................ 116Hepatitis C, acute ................................................................................60Legionellosis ........................................................................................18Leprosy (Hansen’s Disease) ...............................................................19Leptospirosis .......................................................................................20Lyme disease ......................................................................................51Lymphogranuloma venereum ............................................................600Malaria .................................................................................................21Meningitis, pneumococcal ...................................................................25Mumps .................................................................................................28Non-gonococcal urethritis ..................................................................400

O-ZPID ....................................................................................................490Psittacosis ...........................................................................................31Q fever .................................................................................................32Rocky Mountain Spotted Fever ...........................................................35Rubella, congenital syndrome .............................................................37Streptococcal infection, Group A, invasive ..........................................61Tetanus ................................................................................................40Toxic shock syndrome, non-streptococcal ...........................................41Toxic shock syndrome, streptococcal ..................................................65Trichinosis ...........................................................................................42Typhoid, carriage (Salmonella typhi) .................................................144Yellow fever .........................................................................................48

Reportable to Local Health Department Within7 Days

Reportable to Local Health Department Within 24 Hours

Physicians must report these diseases and conditions to the local health department. For diseases and conditions required to be reported within 24 hours, the initial report shall be made by telephone to the local health department, and the written disease report be made within 7 days. The reporting rules and disease report forms can be accessed at:

http://www.epi.state.nc.us/epi/gcdc.html

If you are unable to contact your local health department, call the 24/7 pager for N.C. Communicable Disease Branch: (919) 733-3419

You may be contacted by the local health department for additional information about this case. Medical record information relevant to the investigation and/or control of a communicable disease is exempt from the HIPAA Privacy Rule (see 45 CFR 164.512(a) ) and is permitted as an exception to confidentiality of records in NC State Law GS § 130 A-130.

North Carolina General Statute:§130A-135. Physicians to report.

A physician licensed to practice medicine who has reason to suspect that a person about whom the physician has been consulted professionally has a communicable disease or communicable condition declared by the Commission to be reported, shall report information required by the Commission to the local health director of the county or district in which the physician is consulted.

North Carolina Administrative Code:10A NCAC 41A.0101 Reportable Diseases and Conditions

(a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within the time period specified after the disease or condition is reasonably suspected to exist:

DHHS 2124 (Revised January 2009) EPIDEMIOLOGY

Diseases in Bold itAlics should be reported immediately to local health department.

Page 5: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

CHAPTER 41 - HEALTH: EPIDEMIOLOGY

SUBCHAPTER 41A - COMMUNICABLE DISEASE CONTROL

SECTION .0100 - COMMUNICABLE DISEASE CONTROL

10A NCAC 41A .0101 REPORTABLE DISEASES AND CONDITIONS

(a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby

made reportable within the time period specified after the disease or condition is reasonably suspected to exist:

(1) acquired immune deficiency syndrome (AIDS) - 24 hours;

(2) anthrax - immediately;

(3) botulism - immediately;

(4) brucellosis - 7 days;

(5) campylobacter infection - 24 hours;

(6) chancroid - 24 hours;

(7) chikungunya virus infection - 24 hours;

(8) chlamydial infection (laboratory confirmed) - 7 days;

(9) cholera - 24 hours;

(10) Creutzfeldt-Jakob disease – 7 days;

(11) cryptosporidiosis – 24 hours;

(12) cyclosporiasis – 24 hours;

(13) dengue - 7 days;

(14) diphtheria - 24 hours;

(15) Escherichia coli, shiga toxin-producing - 24 hours;

(16) ehrlichiosis – 7 days;

(17) encephalitis, arboviral - 7 days;

(18) foodborne disease, including Clostridium perfringens, staphylococcal, Bacillus cereus, and other

and unknown causes - 24 hours;

(19) gonorrhea - 24 hours;

(20) granuloma inguinale - 24 hours;

(21) Haemophilus influenzae, invasive disease - 24 hours;

(22) Hantavirus infection – 7 days;

(23) Hemolytic-uremic syndrome – 24 hours;

(24) Hemorrhagic fever virus infection – immediately;

(25) hepatitis A - 24 hours;

(26) hepatitis B - 24 hours;

(27) hepatitis B carriage - 7 days;

(28) hepatitis C, acute – 7 days;

(29) human immunodeficiency virus (HIV) infection confirmed - 24 hours;

(30) influenza virus infection causing death – 24 hours;

(31) legionellosis - 7 days;

(32) leprosy – 7 days;

(33) leptospirosis - 7 days;

(34) listeriosis – 24 hours;

(35) Lyme disease - 7 days;

(36) lymphogranuloma venereum - 7 days;

(37) malaria - 7 days;

(38) measles (rubeola) - 24 hours;

(39) meningitis, pneumococcal - 7 days;

(40) meningococcal disease - 24 hours;

(41) Middle East respiratory syndrome (MERS) - 24 hours;

(42) monkeypox – 24 hours;

(43) mumps - 7 days;

(44) nongonococcal urethritis - 7 days;

(45) novel influenza virus infection – immediately;

(46) plague - immediately;

Page 6: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

(47) paralytic poliomyelitis - 24 hours;

(48) pelvic inflammatory disease – 7 days;

(49) psittacosis - 7 days;

(50) Q fever - 7 days;

(51) rabies, human - 24 hours;

(52) Rocky Mountain spotted fever - 7 days;

(53) rubella - 24 hours;

(54) rubella congenital syndrome - 7 days;

(55) salmonellosis - 24 hours;

(56) severe acute respiratory syndrome (SARS) – 24 hours;

(57) shigellosis - 24 hours;

(58) smallpox - immediately;

(59) Staphylococcus aureus with reduced susceptibility to vancomycin – 24 hours;

(60) streptococcal infection, Group A, invasive disease - 7 days;

(61) syphilis - 24 hours;

(62) tetanus - 7 days;

(63) toxic shock syndrome - 7 days;

(64) trichinosis - 7 days;

(65) tuberculosis - 24 hours;

(66) tularemia – immediately;

(67) typhoid - 24 hours;

(68) typhoid carriage (Salmonella typhi) - 7 days;

(69) typhus, epidemic (louse-borne) - 7 days;

(70) vaccinia – 24 hours;

(71) vibrio infection (other than cholera) – 24 hours;

(72) whooping cough – 24 hours;

(73) yellow fever - 7 days; and

(74) Zika virus infection – 24 hours.

(b) For purposes of reporting, "confirmed human immunodeficiency virus (HIV) infection" is defined as a positive

virus culture, repeatedly reactive EIA antibody test confirmed by western blot or indirect immunofluorescent

antibody test, positive nucleic acid detection (NAT) test, or other confirmed testing method approved by the

Director of the State Public Health Laboratory conducted on or after February 1, 1990. In selecting additional tests

for approval, the Director of the State Public Health Laboratory shall consider whether such tests have been

approved by the federal Food and Drug Administration, recommended by the federal Centers for Disease Control

and Prevention, and endorsed by the Association of Public Health Laboratories.

(c) In addition to the laboratory reports for Mycobacterium tuberculosis, Neisseria gonorrhoeae, and syphilis

specified in G.S. 130A-139, laboratories shall report:

(1) Isolation or other specific identification of the following organisms or their products from human

clinical specimens:

(A) Any hantavirus or hemorrhagic fever virus.

(B) Arthropod-borne virus (any type).

(C) Bacillus anthracis, the cause of anthrax.

(D) Bordetella pertussis, the cause of whooping cough (pertussis).

(E) Borrelia burgdorferi, the cause of Lyme disease (confirmed tests).

(F) Brucella spp., the causes of brucellosis.

(G) Campylobacter spp., the causes of campylobacteriosis.

(H) Chlamydia trachomatis, the cause of genital chlamydial infection, conjunctivitis (adult

and newborn) and pneumonia of newborns.

(I) Clostridium botulinum, a cause of botulism.

(J) Clostridium tetani, the cause of tetanus.

(K) Corynebacterium diphtheriae, the cause of diphtheria.

(L) Coxiella burnetii, the cause of Q fever.

(M) Cryptosporidium parvum, the cause of human cryptosporidiosis.

(N) Cyclospora cayetanesis, the cause of cyclosporiasis.

(O) Ehrlichia spp., the causes of ehrlichiosis.

Page 7: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

(P) Shiga toxin-producing Escherichia coli, a cause of hemorrhagic colitis, hemolytic uremic

syndrome, and thrombotic thrombocytopenic purpura.

(Q) Francisella tularensis, the cause of tularemia.

(R) Hepatitis B virus or any component thereof, such as hepatitis B surface antigen.

(S) Human Immunodeficiency Virus, the cause of AIDS.

(T) Legionella spp., the causes of legionellosis.

(U) Leptospira spp., the causes of leptospirosis.

(V) Listeria monocytogenes, the cause of listeriosis.

(W) Middle East respiratory syndrome virus.

(X) Monkeypox.

(Y) Mycobacterium leprae, the cause of leprosy.

(Z) Plasmodium falciparum, P. malariae, P. ovale, and P. vivax, the causes of malaria in

humans.

(AA) Poliovirus (any), the cause of poliomyelitis.

(BB) Rabies virus.

CC) Rickettsia rickettsii, the cause of Rocky Mountain spotted fever.

(DD) Rubella virus.

(EE) Salmonella spp., the causes of salmonellosis.

(FF) Shigella spp., the causes of shigellosis.

(GG) Smallpox virus, the cause of smallpox.

(HH) Staphylococcus aureus with reduced susceptibility to vanomycin.

(II) Trichinella spiralis, the cause of trichinosis.

(JJ) Vaccinia virus.

(KK) Vibrio spp., the causes of cholera and other vibrioses.

(LL) Yellow fever virus.

(MM) Yersinia pestis, the cause of plague.

(2) Isolation or other specific identification of the following organisms from normally sterile human

body sites:

(A) Group A Streptococcus pyogenes (group A streptococci).

(B) Haemophilus influenzae, serotype b.

(C) Neisseria meningitidis, the cause of meningococcal disease.

(3) Positive serologic test results, as specified, for the following infections:

(A) Fourfold or greater changes or equivalent changes in serum antibody titers to:

(i) Any arthropod-borne viruses associated with meningitis or encephalitis in a

human.

(ii) Any hantavirus or hemorrhagic fever virus.

(iii) Chlamydia psittaci, the cause of psittacosis.

(iv) Coxiella burnetii, the cause of Q fever.

(v) Dengue virus.

(vi) Ehrlichia spp., the causes of ehrlichiosis.

(vii) Measles (rubeola) virus.

(viii) Mumps virus.

(ix) Rickettsia rickettsii, the cause of Rocky Mountain spotted fever.

(x) Rubella virus.

(xi) Yellow fever virus.

(B) The presence of IgM serum antibodies to:

(i) Chlamydia psittaci.

(ii) Hepatitis A virus.

(iii) Hepatitis B virus core antigen.

(iv) Rubella virus.

(v) Rubeola (measles) virus.

(vi) Yellow fever virus.

(4) Laboratory results from tests to determine the absolute and relative counts for the T-helper (CD4)

subset of lymphocytes and all results from tests to determine HIV viral load.

(d) Laboratories utilizing electronic laboratory reporting (ELR) shall report all positive laboratory results from tests

used to diagnose Hepatitis infection, including the following:

Page 8: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

(1) Hepatitis C virus antibody tests (including the test specific signal to cut-off (s/c) ratio;

(2) Hepatitis C nucleic acid tests;

(3) Hepatitis C antigen(s) tests; and

(4) Hepatitis C genotypic tests.

History Note: Authority G.S. 130A-134; 130A-135; 130A-139; 130A-141:

Amended Eff. October 1, 1994; February 1, 1990;

Temporary Amendment Eff. July 1, 1997;

Amended Eff. August 1, 1998;

Temporary Amendment Eff. February 13, 2003; October 1, 2002; February 18, 2002; June 1,

2001;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. November 1, 2003; May 16, 2003;

Amended Eff. January 1, 2005; April 1, 2004;

Temporary Amendment Eff. June 1, 2006;

Amended Eff. April 1, 2008; November 1, 2007; October 1, 2006;

Temporary Amendment Eff. January 1, 2010;

Temporary Amendment Expired September 11, 2011;

Amended Eff. July 1, 2013;

Temporary Amendment Eff. December 2, 2014;

Amended Eff. October 1, 2015;

Emergency Amendment Eff. March 1, 2016;

Temporary Amendment Eff. July 1, 2016;

Amended Eff October 1, 2016.

Page 9: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

10A NCAC 41A .0102 METHOD OF REPORTING

(a) When a report of a disease or condition is required to be made pursuant to G.S. 130A-135 through 139 and 10A

NCAC 41A .0101, with the exception of laboratories, which shall proceed as in Subparagraph (d), the report shall be

made to the local health director as follows:

(1) For diseases and conditions required to be reported within 24 hours, the initial report shall be made by

telephone, and the report required by Subparagraph (2) of this Paragraph shall be made within seven

days.

(2) In addition to the requirements of Subparagraph (1) of this Paragraph, the report shall be made on the

communicable disease report card or in an electronic format provided by the Division of Public Health

and shall include the name and address of the patient, the name and address of the parent or guardian if

the patient is a minor, and epidemiologic information.

(3) In addition to the requirements of Subparagraphs (1) and (2) of this Paragraph, forms or electronic

formats provided by the Division of Public Health for collection of information necessary for disease

control and documentation of clinical and epidemiologic information about the cases shall be

completed and submitted for the following reportable diseases and conditions identified in 10A NCAC

41A .0101(a):

(A) acquired immune deficiency syndrome (AIDS);

(B) brucellosis;

(C) cholera;

(D) cryptosporidiosis;

(E) cyclosporiasis;

(F) E. coli 0157:H7 infection;

(G) ehrlichiosis;

(H) Haemophilus influenzae, invasive disease;

(I) Hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura;

(J) hepatitis A;

(K) hepatitis B;

(L) hepatitis B carriage;

(M) hepatitis C;

(N) human immunodeficiency virus (HIV) confirmed;

(O) legionellosis;

(P) leptospirosis;

(Q) Lyme disease;

(R) malaria;

(S) measles (rubeola);

(T) meningitis, pneumococcal;

(U) meningococcal disease;

(V) mumps;

(W) paralytic poliomyelitis;

(X) psittacosis;

(Y) Rocky Mountain spotted fever;

(Z) rubella;

(AA) rubella congenital syndrome;

(BB) tetanus;

(CC) toxic shock syndrome;

(DD) trichinosis;

(EE) tuberculosis;

(FF) tularemia;

(GG) typhoid;

(HH) typhoid carriage (Salmonella typhi);

(II) vibrio infection (other than cholera); and

(JJ) whooping cough.

Communicable disease report cards, surveillance forms, and electronic formats are available from the Division of Public

Health, 1915 Mail Service Center, Raleigh, North Carolina 27699-1915, and from local health departments.

Page 10: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

(b) Notwithstanding the time frames established in 10A NCAC 41A .0101, a restaurant or other food or drink

establishment shall report all outbreaks or suspected outbreaks of foodborne illness in its customers or employees and all

suspected cases of foodborne disease or foodborne condition in food-handlers at the establishment by telephone to the

local health department within 24 hours in accordance with Subparagraph (a)(1) of this Rule. However, the establishment

is not required to submit a report card or surveillance form pursuant to Subparagraph (a)(2) of this Rule.

(c) For the purposes of reporting by restaurants and other food or drink establishments pursuant to G.S.130A-138, the

following diseases and conditions listed in 10A NCAC 41A .0101(a) shall be reported:

(1) anthrax;

(2) botulism;

(3) brucellosis;

(4) campylobacter infection;

(5) cholera;

(6) cryptosporidiosis;

(7) cyclosporiasis;

(8) E. coli 0157:H7 infection;

(9) hepatitis A;

(10) salmonellosis;

(11) shigellosis;

(12) streptococcal infection, Group A, invasive disease;

(13) trichinosis;

(14) tularemia;

(15) typhoid;

(16) typhoid carriage (Salmonella typhi); and

(17) vibrio infection (other than cholera).

(d) Laboratories required to report test results pursuant to G.S. 130A-139 and 10A NCAC 41A .0101(c) shall report as

follows:

(1) The results of the specified tests for syphilis, chlamydia and gonorrhea shall be reported to the local

health department by the first and fifteenth of each month. Reports of the results of the specified tests

for gonorrhea, chlamydia and syphilis shall include the specimen collection date, the patient's age,

race, and sex, and the submitting physician's name, address, and telephone numbers.

(2) Positive darkfield examinations for syphilis, all reactive prenatal and delivery STS titers, all reactive

STS titers on infants less than one year old and STS titers of 1:8 and above shall be reported within 24

hours by telephone to the HIV/STD Prevention and Care Branch at (919) 733-7301, or the HIV/STD

Prevention and Care Branch Regional Office where the laboratory is located.

(3) With the exception of positive laboratory tests for human immunodeficiency virus, positive laboratory

tests as defined in G.S. 130A-139(1) and 10A NCAC 41A .0101(c) shall be reported to the Division of

Public Health electronically, by mail, by secure telefax or by telephone within the time periods

specified for each reportable disease or condition in 10A NCAC 41A .0101(a). Confirmed positive

laboratory tests for human immunodeficiency virus as defined in 10A NCAC 41A .0101(b) and for

CD4 results defined in 10A NCAC 41A .0101(c)(4) shall be reported to the HIV/STD Prevention and

Care Branch within 24 hours of obtaining reportable test results. Reports shall include as much of the

following information as the laboratory possesses:

(A) the specific name of the test performed;

(B) the source of the specimen;

(C) the collection date(s);

(D) the patient's name, age, race, sex, address, and county; and

(E) the submitting physician's name, address, and telephone number.

History Note: Authority G.S. 130A-134; 130A-135; 130A-138; 130A-139; 130A-141;

Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Eff. March 1, 1988;

Amended Eff. October 1, 1994; February 3, 1992; December 1, 1991; May 1, 1991;

Temporary Amendment Eff. December 16, 1994, for a period of 180 days or until the permanent rule

becomes effective, whichever is sooner;

Temporary Amendment Expired June 16, 1995;

Page 11: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

Amended Eff. December 1, 2007; November 1, 2007; August 1, 2005, April 1, 2003; August 1, 1998.

Page 12: V. Communicable Disease Reporting & Law · (a) The following named diseases and conditions are declared to be dangerous to the public health and are hereby made reportable within

10A NCAC 41A .0103 DUTIES OF LOCAL HEALTH DIRECTOR: REPORT COMMUNICABLE

DISEASES

(a) Upon receipt of a report of a communicable disease or condition pursuant to 10A NCAC 41A .0101, the local health

director shall:

(1) immediately investigate the circumstances surrounding the occurrence of the disease or condition to

determine the authenticity of the report and the identity of all persons for whom control measures are

required. This investigation shall include the collection and submission for laboratory examination of

specimens necessary to assist in the diagnosis and indicate the duration of control measures;

(2) determine what control measures have been given and ensure that proper control measures as provided

in 10A NCAC 41A .0201 have been given and are being complied with;

(3) forward the report as follows:

(A) The local health director shall forward all authenticated reports made pursuant to G.S.

130A-135 to 137 of syphilis, chancroid, granuloma inguinale, and lymphogranuloma

venereum within seven days to the regional office of the Division of Public Health. In

addition, the local health director shall telephone reports of all cases of primary, secondary,

and early latent (under one year's duration) syphilis to the regional office of the HIV/STD

Prevention and Care Branch within 24 hours of diagnosis at the health department or report

by a physician.

(B) The local health director shall telephone all laboratory reports of reactive syphilis serologies

to the regional office of the Division of Public Health within 24 hours of receipt if the person

tested is pregnant. This shall also be done for all other persons tested unless the dilution is

less than 1:8 and the person is known to be over 25 years of age or has been previously

treated. In addition, the written reports shall be sent to the regional office of the Division of

Public Health within seven days.

(C) Except as provided in (a)(3)(A) and (B) of this Rule, a local health director who receives a

report pursuant to 10A NCAC 41A .0102 regarding a person residing in that jurisdiction shall

forward the authenticated report to the Division of Public Health within seven days.

(D) Except as provided in (a)(3)(A) and (B) of this Rule, a local health director who receives a

report pursuant to 10A NCAC 41A .0102 regarding a person who resides in another

jurisdiction in North Carolina shall forward the report to the local health director of that

jurisdiction within 24 hours. A duplicate report card marked "copy" shall be forwarded to

the Division of Epidemiology within seven days.

(E) A local health director who receives a report pursuant to 10A NCAC 41A .0102 regarding a

person who resided outside of North Carolina at the time of onset of the illness shall forward

the report to the Division of Public Health within 24 hours.

(b) If an outbreak exists, the local health director shall submit to the Division of Public Health within 30 days a written

report of the investigation, its findings, and the actions taken to control the outbreak and prevent a recurrence.

(c) Whenever an outbreak of a disease or condition occurs which is not required to be reported by 10A NCAC 41A

.0101 but which represents a significant threat to the public health, the local health director shall give appropriate control

measures consistent with 10A NCAC 41A .0200, and inform the Division of Public Health of the circumstances of the

outbreak within seven days.

History Note: Authority G.S. 130A-141; 130A-144;

Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Eff. March 1, 1988;

Amended Eff. April 1, 2003; December 1, 1991; September 1, 1990.

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10A NCAC 41A .0104 RELEASE OF COMMUNICABLE DISEASE RECORDS: RESEARCH PURPOSES

(a) A person may request, for bona fide research purposes, the release of records which pertain to a communicable disease or

communicable condition and which identify individuals. The request shall be in writing and shall contain the following

information:

(1) Name of organization requesting the data;

(2) Names of principal investigators;

(3) Name of project;

(4) Purpose of project;

(5) Description of the proposed use of the data, including protocols for contacting patients, relatives, and

service providers;

(6) Descriptions of measures to protect the security of the data;

(7) An assurance that the data will not be used for purposes other than those described in the protocol;

(8) An assurance that the data will be properly disposed of upon completion of the project; and

(9) An assurance that the results of the project will be provided to the custodian of the records.

(b) The request for release of the records shall be granted or denied in writing based upon the following considerations:

(1) Whether the objectives of the project require patient identifying information;

(2) Whether the objective of the project can be reached with the use of the data;

(3) Whether the project has a reasonable chance of answering a legitimate research question;

(4) Whether the project might jeopardize the ability of the Epidemiology Division to obtain reports and

information regarding communicable diseases and communicable conditions;

(5) Whether the patient's right to privacy would be adequately protected.

History Note: Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Authority G.S. 130A-143(9);

Eff. March 1, 1988;

Amended Eff. September 1, 1991.

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10A NCAC 41A .0105 HOSPITAL EMERGENCY DEPARTMENT DATA REPORTING

Hospitals, as defined in G.S. 130A-480(d), shall submit electronically to the Division of Public Health the following

electronically available emergency department data elements for all emergency department visits:

(1) Patient record number or other unique identification number;

(2) Patient date of birth and age;

(3) Patient's sex;

(4) City of residence;

(5) County of residence;

(6) Five digit ZIP code;

(7) Alpha numeric patient control number assigned by the hospital for each record (the Visit Identification

Number);

(8) Emergency department facility identification number;

(9) Projected payor source;

(10) Date and time of emergency department visit (first documented time);

(11) Mode of transport to the emergency department;

(12) PreMIS identification number, if transported by EMS;

(13) Chief complaint;

(14) Initial temperature reading and route;

(15) Initial systolic and initial diastolic blood pressure;

(16) Triage Notes (brief description of patient's/family's self-reported illness episode, including symptoms,

duration of symptoms, and reasons for visit [in addition to Chief Complaint] as presented by the

patient or family to the triage nurse upon arrival at the emergency department) – this element is

optional;

(17) Initial emergency department acuity assessment;

(18) Coded cause of injury (ICD-9-CM, if injury related to diagnosis);

(19) Emergency department procedures, up to ten (CPT or ICD-9-CM or ICD-10-CM);

(20) Emergency department disposition;

(21) Emergency department disposition diagnosis description; and

(22) Emergency department disposition diagnosis codes, one primary and up to ten additional (ICD-9-CM

or ICD-10-CM).

History Note: Authority G.S. 130A-480;

Eff. January 1, 2005.

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10A NCAC 41A .0106 REPORTING OF HEALTH CARE-ASSOCIATED INFECTIONS

(a) The following definitions apply throughout this Rule:

(1) "Hospital" means any facility designated as such in G.S. 131E-76(3).

(2) "National Healthcare Safety Network" is an internet-based surveillance system managed by the

Centers for Disease Control and Prevention. This system is designed to be used for the direct,

standardized reporting of healthcare quality information, including health care-associated

infections, by health care facilities to public health entities.

(3) "Health care-associated infection" means a localized or systemic condition in the patient resulting

from an adverse reaction to the presence of an infectious agent(s) or its toxin(s) with no evidence

that the infection was present or incubating when the patient was admitted to the health care

setting.

(4) "Denominator or summary data" refers to referent or baseline data required to generate meaningful

statistics for communicating health care-associated infection rates.

(5) "The Centers for Medicaid and Medicare Services - Inpatient Prospective Payment System (CMS

– IPPS) rules" are regulations promulgated for the disbursement of operating costs by the Centers

for Medicare and Medicaid Services for acute care hospital stays under Medicare Part A based on

prospectively set rates for care.

(b) Hospitals shall electronically report all health care-associated infections required by Paragraph (c) of this Rule

through the National Healthcare Safety Network and shall make the data available to the Department. Hospitals also

shall:

(1) Report all specified health care-associated infections within 30 days following the end of every

calendar month during which the infection was identified;

(2) Report all required health care-associated infection denominator or summary data for healthcare-

associated infections within 30 days following the end of every calendar month; and,

(3) Comply with all reporting requirements for general participation in the National Healthcare Safety

Network.

(c) Except as provided in rules of this Section, hospitals shall report the healthcare-associated infections required by

the Centers for Medicare and Medicaid Services listed in the CMS-IPPS rules beginning on the dates specified

therein. A summary of the HAI reporting requirements from the current copy of the CMS-IPPS rules may be

obtained through the CMS QualityNet site at

http://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier2&cid=122876

0487021

The CMS IPPS rules themselves can be obtained from the CMS IPPS website at

http://www.cms.gov/AcuteInpatientPPS/IPPS2011/list.asp#TopOfPage and

http://www.cms.gov/AcuteInpatientPPS/FR2012/list.asp#TopOfPage. A copy of the current CMS-IPPS rules,

applicable to this section, is available for inspection in the Division of Public Health, 225 N. McDowell Street,

Raleigh NC 27601.

(d) Beginning October 1, 2012 and quarterly thereafter, the Department shall release reports to the public on health

care-associated infection(s) in North Carolina.

History Note: Authority G.S. 130A-150;

Temporary Adoption Eff. November 30, 2011;

Eff. October 1, 2012.

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CHAPTER 41 – HEALTH: EPIDEMIOLOGY

SUBCHAPTER 41A – COMMUNICABLE DISEASE CONTROL

SECTION .0200 - CONTROL MEASURES FOR COMMUNICABLE DISEASES

10A NCAC 41A .0201 CONTROL MEASURES - GENERAL

(a) Except as provided in Rules of this Section, the recommendations and guidelines for testing, diagnosis, treatment,

follow-up, and prevention of transmission for each disease and condition specified by the American Public Health

Association in its publication, Control of Communicable Diseases Manual shall be the required control measures. Control

of Communicable Diseases Manual is hereby incorporated by reference including subsequent amendments and editions.

Guidelines and recommended actions published by the Centers for Disease Control and Prevention shall supercede those

contained in the Control of Communicable Disease Manual and are likewise incorporated by reference, including

subsequent amendments and editions. Copies of the Control of Communicable Diseases Manual may be purchased from

the American Public Health Association, Publication Sales Department, Post Office Box 753, Waldora, MD 20604 for a

cost of twenty-two dollars ($22.00) each plus five dollars ($5.00) shipping and handling. Copies of Centers for Disease

Control and Prevention guidelines contained in the Morbidity and Mortality Weekly Report may be purchased from the

Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402 for a total cost of three dollars

and fifty cents ($3.50) each. Copies of both publications are available for inspection in the Division of Public Health,

1915 Mail Service Center, Raleigh, North Carolina 27699-1915.

(b) In interpreting and implementing the specific control measures adopted in Paragraph (a) of this Rule, and in devising

control measures for outbreaks designated by the State Health Director and for communicable diseases and conditions for

which a specific control measure is not provided by this Rule, the following principles shall be used:

(1) control measures shall be those which can reasonably be expected to decrease the risk of transmission

and which are consistent with recent scientific and public health information;

(2) for diseases or conditions transmitted by the airborne route, the control measures shall require physical

isolation for the duration of infectivity;

(3) for diseases or conditions transmitted by the fecal-oral route, the control measures shall require

exclusions from situations in which transmission can be reasonably expected to occur, such as work as

a paid or voluntary food handler or attendance or work in a day care center for the duration of

infectivity;

(4) for diseases or conditions transmitted by sexual or the blood-borne route, control measures shall

require prohibition of donation of blood, tissue, organs, or semen, needle-sharing, and sexual contact

in a manner likely to result in transmission for the duration of infectivity.

(c) Persons with congenital rubella syndrome, tuberculosis, and carriers of Salmonella typhi and hepatitis B who change

residence to a different local health department jurisdiction shall notify the local health director in both jurisdictions.

(d) Isolation and quarantine orders for communicable diseases and communicable conditions for which control measures

have been established shall require compliance with applicable control measures and shall state penalties for failure to

comply. These isolation and quarantine orders may be no more restrictive than the applicable control measures.

(e) An individual enrolled in an epidemiologic or clinical study shall not be required to meet the provisions of 10A

NCAC 41A .0201 - .0209 which conflict with the study protocol if:

(1) the protocol is approved for this purpose by the State Health Director because of the scientific and

public health value of the study, and

(2) the individual fully participates in and completes the study.

(f) A determination of significant risk of transmission under this Subchapter shall be made only after consideration of the

following factors, if known:

(1) The type of body fluid or tissue;

(2) The volume of body fluid or tissue;

(3) The concentration of pathogen;

(4) The virulence of the pathogen; and

(5) The type of exposure, ranging from intact skin to non-intact skin, or mucous membrane.

(g) The term "household contacts" as used in this Subchapter means any person residing in the same domicile as the

infected person.

History Note: Authority G.S. 130A-135; 130A-144;

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Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Eff. March 1, 1988;

Amended Eff. February 1, 1990; November 1, 1989; August 1, 1988;

Recodified Paragraphs (d), (e) to Rule .0202; Paragraph (i) to Rule .0203 Eff. June 11, 1991;

Amended Eff. April 1, 2003; October 1, 1992; December 1, 1991; August 1, 1998;

Emergency Amendment Eff. January 24, 2005;

Emergency Amendment Expired on April 16, 2005.

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10A NCAC 41A .0202 CONTROL MEASURES – HIV

The following are the control measures for the Acquired Immune Deficiency Syndrome (AIDS) and Human

Immunodeficiency Virus (HIV) infection:

(1) Infected persons shall:

(a) refrain from sexual intercourse unless condoms are used; exercise caution when using

condoms due to possible condom failure;

(b) not share needles or syringes, or any other drug-related equipment, paraphernalia, or works

that may be contaminated with blood through previous use;

(c) not donate or sell blood, plasma, platelets, other blood products, semen, ova, tissues, organs,

or breast milk;

(d) have a skin test for tuberculosis;

(e) notify future sexual intercourse partners of the infection;

(f) if the time of initial infection is known, notify persons who have been sexual intercourse and

needle partners since the date of infection; and,

(g) if the date of initial infection is unknown, notify persons who have been sexual intercourse

and needle partners for the previous year.

(2) The attending physician shall:

(a) give the control measures in Item (1) of this Rule to infected patients, in accordance with 10A

NCAC 41A .0210;

(b) If the attending physician knows the identity of the spouse of an HIV-infected patient and has

not, with the consent of the infected patient, notified and counseled the spouse, the physician

shall list the spouse on a form provided by the Division of Public Health and shall mail the

form to the Division. The Division shall undertake to counsel the spouse. The attending

physician's responsibility to notify exposed and potentially exposed persons is satisfied by

fulfilling the requirements of Sub-Items (2)(a) and (b) of this Rule;

(c) advise infected persons concerning clean-up of blood and other body fluids;

(d) advise infected persons concerning the risk of perinatal transmission and transmission by

breastfeeding.

(3) The attending physician of a child who is infected with HIV and who may pose a significant risk of

transmission in the school or day care setting because of open, oozing wounds or because of

behavioral abnormalities such as biting shall notify the local health director. The local health director

shall consult with the attending physician and investigate the following circumstances:

(a) If the child is in school or scheduled for admission and the local health director determines

that there may be a significant risk of transmission, the local health director shall consult with

an interdisciplinary committee, which shall include school personnel, a medical expert, and

the child's parent or guardian to assist in the investigation and determination of risk. The

local health director shall notify the superintendent or private school director of the need to

appoint such an interdisciplinary committee.

(i) If the superintendent or private school director establishes such a committee within

three days of notification, the local health director shall consult with this committee.

(ii) If the superintendent or private school director does not establish such a committee

within three days of notification, the local health director shall establish such a

committee.

(b) If the child is in school or scheduled for admission and the local health director determines,

after consultation with the committee, that a significant risk of transmission exists, the local

health director shall:

(i) notify the parents;

(ii) notify the committee;

(iii) assist the committee in determining whether an adjustment can be made to the

student's school program to eliminate significant risks of transmission;

(iv) determine if an alternative educational setting is necessary to protect the public

health;

(v) instruct the superintendent or private school director concerning protective

measures to be implemented in the alternative educational setting developed by

school personnel; and

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(vi) consult with the superintendent or private school director to determine which school

personnel directly involved with the child need to be notified of the HIV infection

in order to prevent transmission and ensure that these persons are instructed

regarding the necessity for protecting confidentiality.

(c) If the child is in day care and the local health director determines that there is a significant

risk of transmission, the local health director shall notify the parents that the child must be

placed in an alternate child care setting that eliminates the significant risk of transmission.

(4) When health care workers or other persons have a needlestick or nonsexual non-intact skin or mucous

membrane exposure to blood or body fluids that, if the source were infected with HIV, would pose a

significant risk of HIV transmission, the following shall apply:

(a) When the source person is known:

(i) The attending physician or occupational health care provider responsible for the

exposed person, if other than the attending physician of the person whose blood or

body fluids is the source of the exposure, shall notify the attending physician of the

source that an exposure has occurred. The attending physician of the source person

shall discuss the exposure with the source and, unless the source is already known to

be infected, shall test the source for HIV infection without consent unless it

reasonably appears that the test cannot be performed without endangering the safety

of the source person or the person administering the test. If the source person

cannot be tested, an existing specimen, if one exists, shall be tested. The attending

physician of the exposed person shall be notified of the infection status of the

source.

(ii) The attending physician of the exposed person shall inform the exposed person

about the infection status of the source, offer testing for HIV infection as soon as

possible after exposure and at reasonable intervals up to one year to determine

whether transmission occurred, and, if the source person was HIV infected, give the

exposed person the control measures listed in Sub-Items (1)(a) through (c) of this

Rule. The attending physician of the exposed person shall instruct the exposed

person regarding the necessity for protecting confidentiality.

(b) When the source person is unknown, the attending physician of the exposed persons shall

inform the exposed person of the risk of transmission and offer testing for HIV infection as

soon as possible after exposure and at reasonable intervals up to one year to determine

whether transmission occurred.

(c) A health care facility may release the name of the attending physician of a source person

upon request of the attending physician of an exposed person.

(5) The attending physician shall notify the local health director when the physician, in good faith, has

reasonable cause to suspect a patient infected with HIV is not following or cannot follow control

measures and is thereby causing a significant risk of transmission. Any other person may notify the

local health director when the person, in good faith, has reasonable cause to suspect a person infected

with HIV is not following control measures and is thereby causing a significant risk of transmission.

(6) When the local health director is notified pursuant to Item (5) of this Rule, of a person who is mentally

ill or mentally retarded, the local health director shall confer with the attending mental health physician

or mental health authority and the physician, if any, who notified the local health director to develop a

plan to prevent transmission.

(7) The Division of Public Health shall notify the Director of Health Services of the North Carolina

Department of Correction and the prison facility administrator when any person confined in a state

prison is determined to be infected with HIV. If the prison facility administrator, in consultation with

the Director of Health Services, determines that a confined HIV infected person is not following or

cannot follow prescribed control measures, thereby presenting a significant risk of HIV transmission,

the administrator and the Director shall develop and implement jointly a plan to prevent transmission,

including making recommendations to the unit housing classification committee.

(8) The local health director shall ensure that the health plan for local jails include education of jail staff

and prisoners about HIV, how it is transmitted, and how to avoid acquiring or transmitting this

infection.

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(9) Local health departments shall provide counseling and testing for HIV infection at no charge to the

patient. Third party payors may be billed for HIV counseling and testing when such services are

provided and the patient provides written consent.

(10) HIV pre-test counseling is not required. Post-test counseling for persons infected with HIV is

required, must be individualized, and shall include referrals for medical and psychosocial services and

control measures.

(11) A local health department or the Department may release information regarding an infected person

pursuant to G.S. 130A-143(3) only when the local health department or the Department has provided

direct medical care to the infected person and refers the person to or consults with the health care

provider to whom the information is released.

(12) Notwithstanding Rule .0201(d) of this Section, a local or state health director may require, as a part of

an isolation order issued in accordance with G.S. 130A-145, compliance with a plan to assist the

individual to comply with control measures. The plan shall be designed to meet the specific needs of

the individual and may include one or more of the following available and appropriate services:

(a) substance abuse counseling and treatment;

(b) mental health counseling and treatment; and

(c) education and counseling sessions about HIV, HIV transmission, and behavior change

required to prevent transmission.

(13) The Division of Public Health shall conduct a partner notification program to assist in the notification

and counseling of partners of HIV infected persons.

(14) Every pregnant woman shall be offered HIV testing by her attending physician at her first prenatal visit

and in the third trimester. The attending physician shall test the pregnant woman for HIV infection,

unless the pregnant woman refuses to provide informed consent pursuant to G.S. 130A-148(h). If

there is no record at labor and delivery of an HIV test result during the current pregnancy for the

pregnant woman, the attending physician shall inform the pregnant woman that an HIV test will be

performed, explain the reasons for testing, and the woman shall be tested for HIV without consent

using a rapid HIV test unless it reasonably appears that the test cannot be performed without

endangering the safety of the pregnant woman or the person administering the test. If the pregnant

woman cannot be tested, an existing specimen, if one exists that was collected within the last 24 hours,

shall be tested using a rapid HIV test. The attending physician must provide the woman with the test

results as soon as possible. However, labor and delivery providers who do not currently have the

capacity to perform rapid HIV testing are not required to use a rapid HIV test until January 1, 2009.

(15) If an infant is delivered by a woman with no record of the result of an HIV test conducted during the

pregnancy and if the woman was not tested for HIV during labor and delivery, the fact that the mother

has not been tested creates a reasonable suspicion pursuant to G.S. 130A-148(h) that the newborn has

HIV infection and the infant shall be tested for HIV. An infant born in the previous 12 hours shall be

tested using a rapid HIV test. However, providers who do not currently have the capacity to perform

rapid HIV testing shall not be required to use a rapid HIV test until January 1, 2009.

(16) Testing for HIV may be offered as part of routine laboratory testing panels using a general consent

which is obtained from the patient for treatment and routine laboratory testing, so long as the patient is

notified that they are being tested for HIV and given the opportunity to refuse.

History Note: Authority G.S. 130A-135; 130A-144; 130A-145; 130A-148(h);

Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Eff. March 1, 1988;

Amended Eff. February 1, 1990; November 1, 1989; June 1, 1989;

Temporary Amendment Eff. January 7, 1991 for a period of 180 days to expire on July 6, 1991;

Amended Eff. May 1, 1991;

Recodified from 15A NCAC 19A .0201 (d) and (e) Eff. June 11, 1991;

Amended Eff. August 1, 1995; October 1, 1994; January 4, 1994; October 1, 1992;

Temporary Amendment Eff. February 18, 2002; June 1, 2001;

Amended Eff. November 1, 2007; April 1, 2005; April 1, 2003.

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10A NCAC 41A .0203 CONTROL MEASURES - HEPATITIS B

(a) The following are the control measures for hepatitis B infection. The infected persons shall:

(1) refrain from sexual intercourse unless condoms are used except when the partner is known to be

infected with or immune to hepatitis B;

(2) not share needles or syringes;

(3) not donate or sell blood, plasma, platelets, other blood products, semen, ova, tissues, organs, or breast

milk;

(4) if the time of initial infection is known, identify to the local health director all sexual intercourse and

needle partners since the date of infection; and, if the date of initial infection is unknown, identify

persons who have been sexual intercourse or needle partners during the previous six months;

(5) for the duration of the infection, notify future sexual intercourse partners of the infection and refer

them to their attending physician or the local health director for control measures; and for the duration

of the infection, notify the local health director of all new sexual intercourse partners;

(6) identify to the local health director all current household contacts;

(7) be tested six months after diagnosis to determine if they are chronic carriers, and when necessary to

determine appropriate control measures for persons exposed pursuant to Paragraph (b) of this Rule;

(8) comply with all control measures for hepatitis B infection specified in Paragraph (a) of 10A NCAC

41A .0201, in those instances where such control measures do not conflict with other requirements of

this Rule.

(b) The following are the control measures for persons reasonably suspected of being exposed:

(1) when a person has had a sexual intercourse exposure to hepatitis B infection, the person shall be

tested;

(2) after testing, when a susceptible person has had sexual intercourse exposure to hepatitis B infection,

the person shall be given a dose appropriate for body weight of hepatitis B immune globulin and

hepatitis B vaccination as soon as possible; hepatitis B immune globulin shall be given no later than

two weeks after the last exposure;

(3) when a person is a household contact, sexual intercourse or needle sharing contact of a person who has

remained infected with hepatitis B for six months or longer, the partner or household contact, if

susceptible and at risk of continued exposure, shall be vaccinated against hepatitis B;

(4) when a health care worker or other person has a needlestick, non-intact skin, or mucous membrane

exposure to blood or body fluids that, if the source were infected with the hepatitis B virus, would pose

a significant risk of hepatitis B transmission, the following shall apply:

(A) when the source is known, the source person shall be tested for hepatitis B infection, unless

already known to be infected;

(B) when the source is infected with hepatitis B and the exposed person is:

(i) vaccinated, the exposed person shall be tested for anti-HBs and, if anti-HBs is

unknown or less than 10 milli-International Units per ml, receive hepatitis B

vaccination and hepatitis B immune globulin as soon as possible; hepatitis B

immune globulin shall be given no later than seven days after exposure;

(ii) not vaccinated, the exposed person shall be given a dose appropriate for body

weight of hepatitis B immune globulin immediately and begin vaccination with

hepatitis B vaccine within seven days;

(C) when the source is unknown, the determination of whether hepatitis B immunization is

required shall be made in accordance with current published Control of Communicable

Diseases Manual and Centers for Disease Control and Prevention guidelines. Copies of the

Control of Communicable Diseases Manual may be purchased from the American Public

Health Association, Publication Sales Department, Post Office Box 753, Waldora, MD

20604 for a cost of twenty-two dollars ($22.00) each plus five dollars ($5.00) shipping and

handling. Copies of Center for Disease Control and Prevention guidelines contained in the

Morbidity and Mortality Weekly Report may be purchased from the Superintendent of

Documents, U.S. Government Printing Office, Washington, DC 20402 for a cost of three

dollars fifty cents ($3.50) each. Copies of both publications are available for inspection in

the General Communicable Disease Control Branch, Cooper Memorial Health Building, 225

N. McDowell Street, Raleigh, North Carolina 27603-1382.

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(5) infants born to HBsAg-positive mothers shall be given hepatitis B vaccination and hepatitis B immune

globulin within 12 hours of birth or as soon as possible after the infant is stabilized. Additional doses

of hepatitis B vaccine shall be given in accordance with current published Control of Communicable

Diseases Manual and Centers for Disease Control and Prevention Guidelines. The infant shall be

tested for the presence of HBsAg and anti-HBs within three to nine months after the last dose of the

regular series of vaccine; if required because of failure to develop immunity after the regular series,

additional doses shall be given in accordance with current published Control of Communicable

Diseases Manual and Centers for Disease Control and Prevention guidelines. Copies of the Control of

Communicable Diseases Manual may be purchased from the American Public Health Association,

Publication Sales Department, Post Office Box 753, Waldora, MD 20604 for a cost of twenty-two

dollars ($22.00) each plus five dollars ($5.00) shipping and handling. Copies of Center for Disease

Control and Prevention guidelines contained in the Morbidity and Mortality Weekly Report may be

purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC

20402 for a cost of three dollars fifty cents ($3.50) each. Copies of both publications are available for

inspection in the General Communicable Disease Control Branch, Cooper Memorial Health Building,

225 N. McDowell Street, Raleigh, North Carolina 27603-1382;

(6) infants born to mothers whose HBsAg status is unknown shall be given hepatitis B vaccine within 12

hours of birth and the mother tested. If the tested mother is found to be HBsAg-positive, the infant

shall be given hepatitis B immune globulin as soon as possible and no later than seven days after birth;

(7) when an acutely infected person is a primary caregiver of a susceptible infant less than 12 months of

age, the infant shall receive an appropriate dose of hepatitis B immune globulin and hepatitis

vaccinations in accordance with current published Control of Communicable Diseases Manual and

Centers for Disease Control and Prevention Guidelines. Copies of the Control of Communicable

Diseases Manual may be purchased from the American Public Health Association, Publication Sales

Department, Post Office Box 753, Waldora, MD 20604 for a cost of twenty-two dollars ($22.00) each

plus five dollars ($5.00) shipping and handling. Copies of Center for Disease Control and Prevention

guidelines contained in the Morbidity and Mortality Weekly Report may be purchased from the

Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402 for a cost of

three dollars fifty cents ($3.50) each. Copies of both publications are available for inspection in the

General Communicable Disease Control Branch, Cooper Memorial Health Building, 225 N.

McDowell Street, Raleigh, North Carolina 27603-1382.

(c) The attending physician shall advise all patients known to be at high risk, including injection drug users, men who

have sex with men, hemodialysis patients, and patients who receive multiple transfusions of blood products, that they

should be vaccinated against hepatitis B if susceptible. The attending physician shall also recommend that hepatitis B

chronic carriers receive hepatitis A vaccine (if susceptible).

(d) The following persons shall be tested for and reported in accordance with 10A NCAC 41A .0101 if positive for

hepatitis B infection:

(1) pregnant women unless known to be infected; and

(2) donors of blood, plasma, platelets, other blood products, semen, ova, tissues, or organs.

(e) The attending physician of a child who is infected with hepatitis B virus and who may pose a significant risk of

transmission in the school or day care setting because of open, oozing wounds or because of behavioral abnormalities

such as biting shall notify the local health director. The local health director shall consult with the attending physician

and investigate the circumstances.

(f) If the child referred to in Paragraph (e) of this Rule is in school or scheduled for admission and the local health

director determines that there may be a significant risk of transmission, the local health director shall consult with an

interdisciplinary committee, which shall include school personnel, a medical expert, and the child's parent or guardian to

assist in the investigation and determination of risk. The local health director shall notify the superintendent or private

school director of the need to appoint such an interdisciplinary committee. If the superintendent or private school director

establishes such a committee within three days of notification, the local health director shall consult with this committee.

If the superintendent or private school director does not establish such a committee within three days of notification, the

local health director shall establish such a committee.

(g) If the child referred to in Paragraph (e) of this Rule is in school or scheduled for admission and the local health

director determines, after consultation with the committee, that a significant risk of transmission exists, the local health

director shall:

(1) notify the parents;

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(2) notify the committee;

(3) assist the committee in determining whether an adjustment can be made to the student's school

program to eliminate significant risks of transmission;

(4) determine if an alternative educational setting is necessary to protect the public health;

(5) instruct the superintendent or private school director concerning protective measures to be

implemented in the alternative educational setting developed by school personnel; and

(6) consult with the superintendent or private school director to determine which school personnel directly

involved with the child need to be notified of the hepatitis B virus infection in order to prevent

transmission and ensure that these persons are instructed regarding the necessity for protecting

confidentiality.

(h) If the child referred to in Paragraph (e) of this Rule is in day care and the local health director determines that there is

a significant risk of transmission, the local health director shall notify the parents that the child must be placed in an

alternate child care setting that eliminates the significant risk of transmission.

History Note: Authority G.S. 130A-135; 130A-144

Eff. February 1, 1990;

Amended Eff. October 1, 1990;

Recodified from 15A NCAC 19A .0201(i) Eff. June 11, 1991;

Amended Eff. August 1, 1998; October 1, 1994;

Temporary Amendment Eff. February 18, 2002;

Amended Eff. April 1, 2003.

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10A NCAC 41A .0204 CONTROL MEASURES - SEXUALLY TRANSMITTED DISEASES

(a) Local health departments shall provide diagnosis, testing, treatment, follow-up, and preventive services for syphilis,

gonorrhea, chlamydia, nongonococcal urethritis, mucopurulent cervicitis, chancroid, lymphogranuloma venereum, and

granuloma inguinale. These services shall be provided upon request and at no charge to the patient.

(b) Persons infected with, exposed to, or reasonably suspected of being infected with gonorrhea, chlamydia, non-

gonococcal urethritis, and mucopurulent cervicitis shall:

(1) Refrain from sexual intercourse until examined and diagnosed and treatment is completed, and all

lesions are healed;

(2) Be tested, treated, and re-evaluated in accordance with the STD Treatment Guidelines published by the

U.S. Public Health Service. The recommendations contained in the STD Treatment Guidelines are the

required control measures for testing, treatment, and follow-up for gonorrhea, chlamydia,

nongonococcal urethritis, and mucopurulent cervicitis, and are incorporated by reference including

subsequent amendments and editions. A copy of this publication is on file for public viewing with the

and a copy may be obtained free of charge by writing the Division of Public Health, 1915 Mail Service

Center, Raleigh, North Carolina 27699-1915, and requesting a copy. However, urethral Gram stains

may be used for diagnosis of males rather than gonorrhea cultures unless treatment has failed;

(3) Notify all sexual partners from 30 days before the onset of symptoms to completion of therapy that

they must be evaluated by a physician or local health department.

(c) Persons infected with, exposed to, or reasonably suspected of being infected with syphilis, lymphogranuloma

venereum, granuloma inguinale, and chancroid shall:

(1) Refrain from sexual intercourse until examined and diagnosed and treatment is completed, and all

lesions are healed;

(2) Be tested, treated, and re-evaluated in accordance with the STD Treatment Guidelines published by t h

e U.S. Public Health Service. The recommendations contained in the STD Treatment Guidelines are

the required control measures for testing, treatment, and follow-up for syphilis, lymphogranuloma

venereum, granuloma inguinale, and chancroid, except that chancroid cultures are not required;

(3) Give names to a disease intervention specialist employed by the local health department or by the

Division of Public Health for contact tracing of all sexual partners and others as listed in this Rule:

(A) for syphilis:

(i) congenital - parents and siblings;

(ii) primary - all partners from three months before the onset of symptoms to

completion of therapy and healing of lesions;

(iii) secondary - all partners from six months before the onset of symptoms to

completion of therapy and healing of lesions; and

(iv) latent - all partners from 12 months before the onset of symptoms to completion of

therapy and healing of lesions and, in addition, for women with late latent, spouses

and children;

(B) for lymphogranuloma venereum:

(i) if there is a primary lesion and no buboes, all partners from 30 days before the onset

of symptoms to completion of therapy and healing of lesions; and

(ii) if there are buboes all partners from six months before the onset of symptoms to

completion of therapy and healing of lesions;

(C) for granuloma inguinale - all partners from three months before the onset of symptoms to

completion of therapy and healing of lesions; and

(D) or chancroid - all partners from ten days before the onset of symptoms to completion of

therapy and healing of lesions.

(d) All persons evaluated or reasonably suspected of being infected with any sexually transmitted disease shall be tested

for syphilis, encouraged to be tested confidentially for HIV, and counseled about how to reduce the risk of acquiring

sexually transmitted disease, including the use of condoms.

(e) All pregnant women shall be tested for syphilis, chlamydia and gonorrhea at the first prenatal visit. All pregnant

women shall be tested for syphilis between 28 and 30 weeks of gestation and at delivery. Hospitals shall determine the

syphilis serologic status of the mother prior to discharge of the newborn so that if necessary the newborn can be

evaluated and treated as provided in (c)(2) of this rule. Pregnant women 25 years of age and younger shall be tested for

chlamydia and gonorrhea in the third trimester or at delivery if the woman was not tested in the third trimester.

(f) Any woman who delivers a stillborn infant shall be tested for syphilis.

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(g) All newborn infants shall be treated prophylactically against gonococcal ophthalmia neonatorum in accordance with

the STD Treatment Guidelines published by the U.S. Public Health Service. The recommendations contained in the STD

Treatment Guidelines are the required prophylactic treatment against gonococcal ophthalmia neonatorum.

History Note: Authority G. S. 130A-135; 130A-144;

Eff. December 1, 1991;

Amended Eff. April 1, 2008; November 1, 2007; April 1, 2003; July 1, 1993.

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10A NCAC 41A .0205 CONTROL MEASURES – TUBERCULOSIS

(a) The local health director shall investigate all cases of tuberculosis disease and their contacts in accordance with

recommendations and guidelines published by the Centers for Disease Control and Prevention which are hereby

incorporated by reference including subsequent amendments and editions. The recommendations and guidelines are the

required control measures for tuberculosis, except as otherwise provided in this Rule. A copy of the recommendations

and guidelines is available by contacting the Division of Public Health, 1931 Mail Service Center, Raleigh, North

Carolina 27699-1931 or by accessing the Centers for Disease Control and Prevention website at http://www.cdc.gov/tb.

(b) The following persons shall have a tuberculin skin test (TST) or Interferon Gamma Release Assay (IGRA)

administered in accordance with recommendations and guidelines published by the Centers for Disease Control and

Prevention:

(1) Household and other high priority contacts of active cases of pulmonary and laryngeal tuberculosis.

For purposes of this Rule, a high priority contact is defined in accordance with Centers for Disease

Control and Prevention guidelines. If the contact's initial skin or IGRA test is negative, and the case is

confirmed by culture, a repeat skin or IGRA test shall be performed 8 to 10 weeks after the exposure

has ended;

(2) Persons reasonably suspected of having tuberculosis disease;

(3) Inmates in the custody of the Department of Public Safety, Division of Adult Correction upon

incarceration, and annually thereafter;

(4) Persons with HIV infection or AIDS.

(c) The following persons shall be tested using a two-step skin test method or a single IGRA test, administered in

accordance with recommendations and guidelines published by the Centers for Disease Control and Prevention:

(1) Staff with direct inmate contact in the Department of Public Safety, Division of Adult Correction upon

employment;

(2) Staff of licensed nursing homes or adult care homes upon employment;

(3) Residents upon admission to licensed nursing homes or adult care homes. If the individual is being

admitted directly from another hospital, licensed nursing home or adult care home in North Carolina

and there is documentation of a two-step skin test or a single IGRA test, the individual does not need

to be retested;

(4) Staff in adult day care centers providing care for persons with HIV infection or AIDS upon

employment.

(d) Except as provided in the last sentence of Subparagraph (c)(3) of this Rule, persons listed in Paragraph (c) of this

rule shall be required only to have a single TST or IGRA in the following situations:

(1) If the person has ever had a two-step skin test; or

(2) If the person has had a single skin test within the last twelve months.

(e) Persons with a positive tuberculin skin test or IGRA shall be evaluated by an interview to screen for symptoms and a

chest x-ray if they do not have a documented chest x-ray that was performed on the date of the positive test or later.

(f) Treatment and follow-up for tuberculosis infection or disease shall be in accordance with the recommendations and

guidelines from the Centers for Disease Control and Prevention.

(g) Persons with active tuberculosis disease shall complete a standard multi-drug regimen, and shall be managed using

Directly Observed Therapy (DOT), which is the actual observation of medication ingestion by a health care worker

(HCW).

If a standard multi-drug regimen cannot be used, the attending physician shall consult with the state Tuberculosis Medical

Director or designee on the treatment plan.

(h) Persons with suspected or known active pulmonary or laryngeal tuberculosis who have sputum smears positive for

acid fast bacilli shall be considered infectious and shall be managed using airborne precautions including respiratory

isolation or isolation in their home with no new persons exposed. These individuals are considered noninfectious and use

of airborne precautions, precautions including respiratory isolation or isolation in their home may be discontinued when:

(1) Sputum specimen results meet Centers for Disease Control and Prevention criteria for discontinuation

of respiratory isolation;

(2) They have two consecutive sputum smears collected at least eight hours apart which are negative;

(3) It has been at least seven days since the last positive sputum smear; and

(4) They have been compliant on tuberculosis medications to which the organism is susceptible and there

is evidence of clinical response to tuberculosis treatment.

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(i) Persons with suspected or known active pulmonary or laryngeal tuberculosis who are initially sputum smear negative

require respiratory isolation until they have been started on tuberculosis treatment to which the organism is susceptible

and there is evidence of clinical response to treatment.

History Note: Authority G.S. 130A-135; 130A-144;

Eff. March 1, 1992;

Amended Eff. April 1, 2006; April 1, 2003; August 1, 1998; October 1, 1994;

Temporary Amendment Eff. August 1, 2011;

Amended Eff. July 1, 2012.

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10A NCAC 41A .0206 INFECTION PREVENTION – HEALTH CARE SETTINGS

(a) The following definitions apply throughout this Rule:

(1) "Health care organization" means a hospital; clinic; physician, dentist, podiatrist, optometrist, or

chiropractic office; home care agency; nursing home; local health department; community health

center; mental health facility; hospice; ambulatory surgical facility; urgent care center; emergency

room; Emergency Medical Service (EMS) agency; pharmacies where a health practitioner offers

clinical services; or any other organization that provides clinical care.

(2) "Invasive procedure" means entry into tissues, cavities, or organs or repair of traumatic injuries. The

term includes the use of needles to puncture skin, vaginal and cesarean deliveries, surgery, and dental

procedures during which bleeding occurs or the potential for bleeding exists.

(3) "Non-contiguous" means not physically connected.

(b) In order to prevent transmission of HIV, hepatitis B, hepatitis C and other bloodborne pathogens each health care

organization that performs invasive procedures shall implement a written infection control policy. The health care

organization shall ensure that health care workers in its employ or who have staff privileges are trained in the principles

of infection control and the practices required by the policy; require and monitor compliance with the policy; and update

the policy as needed to prevent transmission of HIV, hepatitis B, hepatitis C and other bloodborne pathogens. The health

care organization shall designate one on-site staff member for each noncontiguous facility to direct these activities. The

designated staff member in each health care facility shall complete a course in infection control approved by the

Department. The Department shall approve a course that addresses:

(1) Epidemiologic principles of infectious disease;

(2) Principles and practice of asepsis;

(3) Sterilization, disinfection, and sanitation;

(4) Universal blood and body fluid precautions;

(5) Safe injection practices;

(6) Engineering controls to reduce the risk of sharp injuries;

(7) Disposal of sharps; and

(8) Techniques that reduce the risk of sharp injuries to health care workers.

(c) The infection control policy required by this Rule shall address the following components that are necessary to

prevent transmission of HIV, hepatitis B, hepatitis C and other bloodborne pathogens:

(1) Sterilization and disinfection, including a schedule for maintenance and microbiologic monitoring of

equipment; the policy shall require documentation of maintenance and monitoring;

(2) Sanitation of rooms and equipment, including cleaning procedures, agents, and schedules;

(3) Accessibility of infection control devices and supplies; and

(4) Procedures to be followed in implementing 10A NCAC 41A .0202(4) and .0203(b)(4) when a health

care provider or a patient has an exposure to blood or other body fluids of another person in a manner

that poses a significant risk of transmission of HIV or hepatitis B.

(d) Health care workers and emergency responders shall, with all patients, follow Centers for Disease Control and

Prevention Guidelines on blood and body fluid precautions incorporated by reference in 10A NCAC 41A .0201.

(e) Health care workers who have exudative lesions or weeping dermatitis shall refrain from handling patient care

equipment and devices used in performing invasive procedures and from all direct patient care that involves the potential

for contact of the patient, equipment, or devices with the lesion or dermatitis until the condition resolves.

(f) All equipment used to puncture skin, mucous membranes, or other tissues in medical, dental, or other settings must be

disposed of in accordance with 15A NCAC 13B .1200 after use or sterilized prior to reuse.

History Note: Authority G.S. 130A-144; 130A-145; 130A-147;

Eff. October 1, 1992;

Amended Eff. January 1, 2010; December 1, 2003; July 1, 1994; January 4, 1994.

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10A NCAC 41A .0207 HIV AND HEPATITIS B INFECTED HEALTH CARE WORKERS

(a) The following definitions shall apply throughout this Rule:

(1) "Surgical or obstetrical procedures" means vaginal deliveries or surgical entry into tissues, cavities, or

organs. The term does not include phlebotomy; administration of intramuscular, intradermal, or

subcutaneous injections; needle biopsies; needle aspirations; lumbar punctures; angiographic

procedures; endoscopic and bronchoscopic procedures; or placing or maintaining peripheral or central

intravascular lines.

(2) "Dental procedure" means any dental procedure involving manipulation, cutting, or removal of oral or

perioral tissues, including tooth structure during which bleeding occurs or the potential for bleeding

exists. The term does not include the brushing of teeth.

(b) All health care workers who perform surgical or obstetrical procedures or dental procedures and who know

themselves to be infected with HIV or hepatitis B shall notify the State Health Director. Health care workers who assist

in these procedures in a manner that may result in exposure of patients to their blood and who know themselves to be

infected with HIV or hepatitis B shall also notify the State Health Director. The notification shall be made in writing to

the Chief, Communicable Disease Control Branch, 1902 Mail Service Center, Raleigh, NC 27699-1902..

(c) The State Health Director shall investigate the practice of any infected health care worker and the risk of transmission

to patients. The investigation may include review of medical and work records and consultation with health care

professionals who may have information necessary to evaluate the clinical condition or practice of the infected health

care worker. The attending physician of the infected health care worker shall be consulted. The State Health Director

shall protect the confidentiality of the infected health care worker and may disclose the worker's infection status only

when essential to the conduct of the investigation or periodic reviews pursuant to Paragraph (h) of this Rule. When the

health care worker's infection status is disclosed, the State Health Director shall give instructions regarding the

requirement for protecting confidentiality.

(d) If the State Health Director determines that there may be a significant risk of transmission of HIV or hepatitis B to

patients, the State Health Director shall appoint an expert panel to evaluate the risk of transmission to patients, and

review the practice, skills, and clinical condition of the infected health care worker, as well as the nature of the surgical or

obstetrical procedures or dental procedures performed and operative and infection control techniques used. Each expert

panel shall include an infectious disease specialist, an infection control expert, a person who practices the same

occupational specialty as the infected health care worker and, if the health care worker is a licensed professional, a

representative of the appropriate licensure board. The panel may include other experts. The State Health Director shall

consider for appointment recommendations from health care organizations and local societies of health care

professionals.

(e) The expert panel shall review information collected by the State Health Director and may request that the State

Health Director obtain additional information as needed. The State Health Director shall not reveal to the panel the

identity of the infected health care worker. The infected health care worker and the health care worker's attending

physician shall be given an opportunity to present information to the panel. The panel shall make recommendations to

the State Health Director that address the following:

(1) Restrictions that are necessary to prevent transmission from the infected health care worker to patients;

(2) Identification of patients that have been exposed to a significant risk of transmission of HIV or

hepatitis B; and

(3) Periodic review of the clinical condition and practice of the infected health care worker.

(f) If, prior to receipt of the recommendations of the expert panel, the State Health Director determines that immediate

practice restrictions are necessary to prevent an imminent threat to the public health, the State Health Director shall issue

an isolation order pursuant to G.S. 130A-145. The isolation order shall require cessation or modification of some or all

surgical or obstetrical procedures or dental procedures to the extent necessary to prevent an imminent threat to the public

health. This isolation order shall remain in effect until an isolation order is issued pursuant to Paragraph (g) of this Rule

or until the State Health Director determines the imminent threat to the public health no longer exists.

(g) After consideration of the recommendations of the expert panel, the State Health Director shall issue an isolation

order pursuant to G.S. 130A-145. The isolation order shall require any health care worker who is allowed to continue

performing surgical or obstetrical procedures or dental procedures to, within a time period specified by the State Health

Director, successfully complete a course in infection control procedures approved by the Department of Health and

Human Services, General Communicable Disease Control Branch, in accordance with 10A NCAC 41A .0206(e). The

isolation order shall require practice restrictions, such as cessation or modification of some or all surgical or obstetrical

procedures or dental procedures, to the extent necessary to prevent a significant risk of transmission of HIV or hepatitis B

to patients. The isolation order shall prohibit the performance of procedures that cannot be modified to avoid a

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significant risk of transmission. If the State Health Director determines that there has been a significant risk of

transmission of HIV or hepatitis B to a patient, the State Health Director shall notify the patient or assist the health care

worker to notify the patient.

(h) The State Health Director shall request the assistance of one or more health care professionals to obtain information

needed to periodically review the clinical condition and practice of the infected health care worker who performs or

assists in surgical or obstetrical procedures or dental procedures.

(i) An infected health care worker who has been evaluated by the State Health Director shall notify the State Health

Director prior to a change in practice involving surgical or obstetrical procedures or dental procedures. The infected

health care worker shall not make the proposed change without approval from the State Health Director. If the State

Health Director makes a determination in accordance with Paragraph (c) of this Rule that there is a significant risk of

transmission of HIV or hepatitis B to patients, the State Health Director shall appoint an expert panel in accordance with

Paragraph (d) of this Rule. Otherwise, the State Health Director shall notify the health care worker that he or she may

make the proposed change in practice.

(j) If practice restrictions are imposed on a licensed health care worker, a copy of the isolation order shall be provided to

the appropriate licensure board. The State Health Director shall report violations of the isolation order to the appropriate

licensure board. The licensure board shall report to the State Health Director any information about the infected health

care worker that may be relevant to the risk of transmission of HIV or hepatitis B to patients.

History Note: Authority G.S. 130A-144; 130A-145;

Eff. October 1, 1992;

Amended Eff. April 1, 2003.

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10A NCAC 41A .0208 CONTROL MEASURES -- SMALLPOX; VACCINIA DISEASE

(a) Guidelines and recommended actions for prevention of the spread of smallpox and for prevention of the spread of

vaccinia published by the Center for Disease Control and Prevention (CDC) shall supercede those contained in the

control of Communicable Disease Manual and are incorporated by reference, including subsequent amendments and

editions. Copies of CDC guidelines contained in the Morbidity and Mortality weekly reports may be purchased from the

Superintendent of Documents, US Government Printing Office, Washington DC 20402 for a total cost of three dollars

and fifty cents ($3.50) each.

(b) The attending physician of a person vaccinated against smallpox shall report to the local health department the

existence of any of the following:

(1) autoinnoculation;

(2) generalized vaccinia;

(3) eczema vaccinatum;

(4) progressive vaccinia; and

(5) post vaccination encephalitis.

The attending physician shall make the report to the local health department within 24 hours. The local health

department shall notify the Division of Public Health within 24 hours.

(c) The physician responsible for vaccinating a person against smallpox and the physician diagnosing a person with

vaccinia disease shall instruct the patient to follow CDC guidelines for the prevention of the spread of vaccinia adopted

by reference in Paragraph (a) of this Rule. The patient shall follow these guidelines.

(d) The State Health Director or a local health director may use isolation authority pursuant to G.S. 130A-145 when

necessary to prevent the spread of smallpox or vaccinia virus.

History Note: Authority G.S. 130A-144;

Temporary Adoption Eff. February 13, 2003;

Eff. August 1, 2004.

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10A NCAC 41A .0209 LABORATORY TESTING

All laboratories shall do the following:

(1) When Neisseria meningitidis is isolated from a normally sterile site, test the organism for specific

serogroup or send the isolate to the State Laboratory of Public Health for serogrouping;

(2) When a stool culture is requested on a specimen from a person with bloody diarrhea, culture the

stool for shiga-toxin producing Escherichia coli or send the specimen to the State Laboratory of

Public Health;

(3) When Haemophilus influenzae is isolated, test the organism for specific serogroup or send the

isolate to the State Laboratory of Public Health for serogrouping; and

(4) When Mycobacterium tuberculosis complex is isolated, test the organism for specific restriction

fragment length polymorphism (RFLP) or send the isolate, or a subculture of the isolate, to the

State Laboratory of Public Health for genotyping.

History Note: Authority G.S. 130A-139;

Eff. October 1, 1994;

Temporary Amendment Eff. February 18, 2002;

Amended Eff. April 1, 2004; April 1, 2003.

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10A NCAC 41A .0210 DUTIES OF ATTENDING PHYSICIANS

Immediately upon making a diagnosis of or reasonably suspecting a communicable disease or communicable condition for

which control measures are provided in Rule .0201, .0202 or .0203 of this Section, the attending physician shall instruct the

patient and any other person specified in those control measures to carry out those control measures and shall give sufficiently

detailed instructions for proper compliance, or the physician shall request the local health director to give such instruction.

When making the initial telephone report for diseases and conditions required to be reported within 24 hours, the physician

shall inform the local health director of the control measures given.

History Note: Filed as a Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Authority G.S. 130A-144;

Eff. March 1, 1988;

Recodified from 15A NCAC 19A .0202 Eff. June 11, 1991.

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10A NCAC 41A .0211 DUTIES OF OTHER PERSONS

(a) The local health director may reveal the identity and diagnosis of a person with a reportable communicable disease or

communicable condition or other communicable disease or communicable condition which represents a significant threat to

the public health to those persons specified in Paragraph (b) when disclosure is necessary to prevent transmission in the

facility or establishment for which they are responsible. The local health director shall ensure that all persons so notified are

instructed regarding the necessity for protecting confidentiality.

(b) The following persons shall require that any person about whom they are notified pursuant to Paragraph (a) comply with

control measures given by the local health director to prevent transmission in the facility or establishment:

(1) the principal of any private or public school;

(2) employers;

(3) superintendents or directors of all public or private institutions, hospitals, or jails; and

(4) operators of a child day care center, child day care home, or other child care providers.

(c) The provisions of Paragraphs (a) and (b) shall not apply with regard to gonorrhea, syphilis, chancroid, granuloma

inguinale, lymphogranuloma venereum, chlamydia, non-gonococcal urethritis, AIDS, and HIV infection. However, persons

may be notified with regard to these diseases and conditions in accordance with 10A NCAC 41A .0201, .0202 or .0203 of this

Section.

History Note: Filed as a Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Authority G.S. 130A-143; 130A-144;

Eff. March 1, 1988;

Amended Eff. June 1, 1989;

Recodified from 15A NCAC 19A .0203 Eff. June 11, 1991.

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10A NCAC 41A .0212 HANDLING AND TRANSPORTATION OF BODIES

(a) It shall be the duty of the physician attending any person who dies and is known to be infected with HIV, plague,

or hepatitis B or any person who dies and is known or reasonably suspected to be infected with smallpox, rabies,

severe acute respiratory syndrome (SARS), or Jakob-Creutzfeldt to provide written notification to all individuals

handling the body of the proper precautions to prevent infection. This written notification shall be provided to

funeral service personnel at the time the body is removed from any hospital, nursing home, or other health care

facility. When the patient dies in a location other than a health care facility, the attending physician shall notify the

funeral service personnel verbally of the precautions required as soon as the physician becomes aware of the death.

These precautions are noted in Paragraphs (b) and (c).

(b) The body of any person who died and is known or reasonably suspected to be infected with smallpox or severe

acute respiratory syndrome (SARS) or any person who died and is known to be infected with plague shall not be

embalmed. The body shall be enclosed in a strong, tightly sealed outer case which will prevent leakage or escape of

odors as soon as possible after death and before the body is removed from the hospital room, home, building, or

other premises where the death occurred. This case shall not be reopened except with the consent of the local health

director. Nothing in this Paragraph shall prohibit cremation.

(c) Persons handling the body of any person who died and is known to be infected with HIV or hepatitis B or any

person who died and is known or reasonably suspected to be infected with Jakob-Creutzfeldt or rabies shall be

provided written notification to observe blood and body fluid precautions.

History Note: Authority G.S. 130A-144; 130A-146;

Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988; Eff.

March 1, 1988; Recodified from 15A NCAC 19A .0204 Eff. June 11, 1991;

Temporary Amendment Eff. November 1, 2003;

Amended Eff. April 1, 2004.

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10A NCAC 41A .0213 CONTROL MEASURES -- SARS

Guidelines and recommended actions for prevention of the spread of Severe Acute Respiratory Syndrome (SARS)

published by the Centers for Disease Control and Prevention (CDC) shall be the required control measures for SARS and

are incorporated by reference, including subsequent amendments and editions. Copies of CDC guidelines contained in

the Morbidity and Mortality weekly reports may be purchased from the Superintendent of Documents, US Government

Printing Office, Washington DC 20402 for a total cost of three dollars and fifty cents ($3.50) each.

History Note: Authority G.S. 130A-144;

Temporary Adoption Eff. May 16, 2003;

Eff. August 1, 2004.

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10A NCAC 41A .0214 CONTROL MEASURES - HEPATITIS C

The following are the control measures for hepatitis C infection:

(1) Infected persons shall not:

(a) share needles or syringes, any other drug-related equipment or paraphernalia, or personal

items, such as razors, that may be contaminated with blood through previous use; or

(b) donate or sell blood, plasma, platelets, or other blood products.

(2) Persons with acute hepatitis C infection shall:

(a) if the date of initial infection is known, identify to the local health director all needle partners

since the date of infection;

(b) if the date of initial infection is unknown, identify persons who have been needle partners

during the previous six months.

(3) The attending physician shall:

(a) advise all patients known to be at high risk, including injection drug users, hemodialysis

patients, patients who received blood transfusions or solid organ transplants before July

1992, patients who received clotting factor concentrates made before 1987, persons with HIV

infection, and persons with known exposure to hepatitis C, that they should be tested for

hepatitis C;

(b) advise infected persons of the potential for transmission to others via blood or body fluids;

(c) provide or recommend that the infected patient seek medical evaluation for the presence or

development of chronic liver disease; and

(d) recommend that persons with chronic hepatitis C receive hepatitis A and hepatitis B vaccines

unless serological testing indicates that they are immune to these infections by virtue of past

infection or vaccination.

(4) When a health care worker or other person has a needlestick, non-intact skin, or mucous membrane

exposure to blood or body fluids that would pose a significant risk of hepatitis C transmission if the

source were infected with the hepatitis C virus, the following apply:

(a) When the source is known, the attending physician or occupational health care provider

responsible for the exposed person, if other than the attending physician of the person whose

blood or body fluids is the source of the exposure, shall notify the attending physician of the

source that an exposure has occurred. The attending physician of the source person shall

discuss the exposure with the source and, unless the source is already known to be infected,

shall test the source for hepatitis C virus infection with or without consent unless it

reasonably appears that the test cannot be performed without endangering the safety of the

source person or the person administering the test. If the source person cannot be tested, an

existing specimen of his or her blood, if one exists, shall be tested. The attending physician of

the source person shall notify the attending physician of the exposed person of the infection

status of the source.

(b) The attending physician of the exposed person shall inform the exposed person about the

infection status of the source and shall instruct the exposed person regarding the necessity for

protecting confidentiality. If the source person is infected with hepatitis C virus or the source

person’s infection status is unknown, the attending physician of the exposed person shall

advise the exposed person to seek testing for hepatitis C virus infection as soon as possible

and again four to six months after the exposure. If the source person was hepatitis C virus

infected, the attending physician shall inform the exposed person of the measures required in

Sub-Items (1)(a) through (b) of this Rule.

(5) The Centers for Disease Control and Prevention (CDC) Nationally Notifiable Diseases and Conditions

(NNDC) Current Case Definitions for Hepatitis C are hereby incorporated by reference, including

subsequent amendments and editions. The CDC NNDC may be accessed from the internet at

(http://www.cdc.gov/osels/ph_surveillance/nndss/phs/infdis.htm). This document is also available for

inspection at the North Carolina Division of Public Health, 1902 Mail Service Center, Raleigh NC

27603.

History Note: Authority G.S. 130A-135; 130A-144;

Eff. April, 1, 2012.

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SECTION .0300 - SPECIAL CONTROL MEASURES

10A NCAC 41A .0301 DEFINITIONS

The following definitions shall apply in the interpretation of 10A NCAC 41A .0302:

(1) "Turtle" means any reptile of the order Testudines.

(2) "Institution" means a school, college, university, research laboratory, or other facility having a bona fide

research or teaching interest in turtles.

History Note: Authority G.S. 130A-144;

Eff. February 1, 1976;

Readopted Eff. December 5, 1977;

Amended Eff. May 1, 1992.

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10A NCAC 41A .0302 SALE OF TURTLES RESTRICTED

(a) To prevent the spread of salmonellosis from pet turtles to humans, no turtle with a carapace length of less than

four inches shall be sold, offered for sale, or bartered by any retail or wholesale establishments except as follows:

(1) the sale of turtles shall be allowed to institutions for scientific or educational purposes;

(2) the sale of turtles shall be allowed for food purposes; and

(3) wholesale establishments dealing in the sale of turtles shall be allowed to sell turtles to other

wholesale or retail establishments outside of the State of North Carolina, subject to the applicable

state and federal laws.

(b) For establishments selling turtles in accordance with Paragraph (a) of this Rule, the following information, or

words having similar meaning, shall be posted at every display of turtles for retail sale, printed on the sales receipt

issued by the seller at the time of the sale, or printed on an information sheet accompanying the sales receipt issued

by the seller:

"CAUTION: Children under 5 years old and people with weak immune systems (such as chemotherapy

patients or those with HIV/AIDS) should avoid contact with reptiles. These people can get very sick from a

germ called Salmonella that reptiles carry. Reptiles include lizards, snakes, alligators, and turtles. Wash

hands thoroughly after handling turtles or material that had contact with turtles. Do not allow water or any

other substance that had contact with turtles to come in contact with food or areas where food is prepared.

Do not bathe turtles or clean their tanks in your kitchen or bathroom and do not have close contact with

turtles which could allow direct contamination of the mouth (e.g., kissing, etc.)."

(c) The seller shall keep a record of all purchases, losses, and other dispositions of turtles for at least one year.

History Note: Authority G.S. 130A-144;

Eff. February 1, 1976;

Readopted Eff. December 5, 1977;

Amended Eff. May 1, 2017; February 3, 1992.

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10A NCAC 41A .0303 RECORDING THE SALES OF BIRDS

(a) A business engaged in the retail sale of birds shall maintain a record of each sale for at least six months after the sale. The

record shall include the name and address of the purchaser of each bird. The record shall be made available to the

Department upon the request of the Department.

(b) This Rule shall not apply to the sale of birds for hunting, scientific, educational, agricultural or food purposes.

History Note: Authority G.S. 130A-144;

Eff. June 1, 1990.

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SECTION .0400 - IMMUNIZATION

10A NCAC 41A .0401 DOSAGE AND AGE REQUIREMENTS FOR IMMUNIZATION

(a) Every individual in North Carolina required to be immunized pursuant to G.S. 130A-152 through 130A-157 shall be

immunized against the following diseases and have documentation of age-appropriate vaccination in accordance with the

Advisory Committee on Immunization Practices (ACIP).

(1) Diphtheria, tetanus, and pertussis (whooping cough) - five doses: three doses by age seven months;

and 2 booster doses, the first by age 19 months and the second on or after the fourth birthday and

before entering school for the first time. However:

(A) Individuals who receive the first booster dose of diphtheria/tetanus/pertussis vaccine on or

after the fourth birthday are not required to have a second booster.

(B) Individuals entering college or university for the first time on or after July 1, 2008 must have

had three doses of tetanus/diphtheria toxoid; one of which must be

tetanus/diphtheria/pertussis.

(C) A booster dose of tetanus/diphtheria/pertussis vaccine is required for individuals who have

not previously received it and are entering the seventh grade or by 12 years of age, whichever

comes first.

(2) Poliomyelitis vaccine - four doses: two doses of trivalent type by age five months; a third dose

trivalent type before age 19 months; and a booster dose of trivalent type on or after his or her fourth

birthday and before entering school for the first time. However:

(A) An individual attending school who has attained his or her 18th birthday is not required to

receive a polio vaccine.

(B) The requirements for the booster dose on or after the fourth birthday do not apply to

individuals who began school before July 1, 2015.

(C) Individuals who receive the third dose of poliomyelitis vaccine on or after the fourth birthday

are not required to receive a fourth dose if the third dose is given at least six months after the

second dose.

(3) Measles (rubeola) vaccine - two doses of live, attenuated vaccine administered at least 28 days apart:

the first dose on or after age 12 months and before age 16 months; and a second dose before entering

school for the first time. However:

(A) An individual who has been documented by serological testing to have a protective antibody

titer against measles is not required to receive measles vaccine.

(B) An individual who has been diagnosed before January 1, 1994, by a physician (or designee

such as a nurse practitioner or physician's assistant) as having measles (rubeola) disease is not

required to receive measles vaccine.

(C) An individual born before 1957 is not required to receive measles vaccine except in measles

outbreak situations.

(D) The requirement for a second dose of measles vaccine does not apply to individuals who

enter school or in college or university for the first time before July 1, 1994.

(4) Rubella vaccine - one dose of live, attenuated vaccine on or after age 12 months and before age 16

months. However:

(A) An individual who has laboratory confirmation of rubella disease or who has been

documented by serological testing to have a protective antibody titer against rubella is not

required to receive rubella vaccine.

(B) An individual who has attained his or her fiftieth birthday is not required to receive rubella

vaccine except in outbreak situations.

(C) An individual who entered a college or university after his or her thirtieth birthday and before

February 1, 1989 is not required to meet the requirement for rubella vaccine except in

outbreak situations.

(5) Mumps vaccine – two doses: the first dose of live, attenuated vaccine administered on or after age 12

months and before age 16 months; and a second dose before entering school, college or university for

the first time. However:

(A) An individual who has laboratory confirmation of disease, or has been documented by

serological testing to have a protective antibody titer against mumps is not required to receive

the mumps vaccine.

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(B) An individual born before 1957 is not required to receive the mumps vaccine.

(C) The requirements for the mumps vaccine do not apply to individuals who entered the first

grade for the first time before July 1, 1987 or college or university before July 1, 1994.

(D) An individual entering school, college or university before July 1, 2008 is not required to

receive a second dose of mumps vaccine.

(6) Haemophilus influenzae, b conjugate vaccine - three doses of HbOC or PRP-T or two doses of PRP-

OMP before age 7 months and a booster dose of any type on or after age 12 months and by age 16

months. However:

(A) Individuals who receive the first dose of Haemophilus influenzae, b vaccine on or after 7

months of age and before 12 months of age are required to have two doses of HbOC, PRP-T

or PRP-OMP and a booster dose on or after 12 months of age and by age 16 months.

(B) Individuals who receive the first dose of Haemophilus influenzae, b vaccine on or after 12

months of age and before 15 months of age are required to have only 2 doses of HbOC, PRP-

T or PRP-OMP and a booster dose two months later.

(C) Individuals who receive the first dose of Haemophilus influenzae, b vaccine on or after 15

months of age are required to have only one dose of any of the Haemophilus influenzae b

conjugate vaccines.

(D) No individual who has passed his or her fifth birthday is required to be vaccinated against

Haemophilus influenzae, b.

(7) Hepatitis B vaccine – three doses: the first dose by age 3 months, a second dose before age 5 months

and a third dose by age 19 months. However:

(A) The last dose of the hepatitis B vaccine series shall not be administered before 24 weeks of

age.

(B) Individuals born before July 1, 1994 are not required to be vaccinated against hepatitis B.

(8) Varicella vaccine – two doses administered at least 28 days apart; one dose on or after age 12 months

of age and before age 19 months; and a second dose before entering school for the first time. However:

(A) An individual who has laboratory confirmation of varicella disease immunity or has been

documented by serological testing to have a protective antibody titer against varicella is not

required to varicella vaccine.

(B) An individual who has documentation from a physician, nurse practitioner, or physician's

assistant verifying history of varicella disease is not required to receive varicella vaccine. The

documentation shall include the name of the individual with a history of varicella disease, the

approximate date or age of infection, and a healthcare provider signature.

(C) An individual born before April 1, 2001 is not required to receive varicella vaccine.

(D) The requirement for the second dose of varicella vaccine shall not apply to individuals who

enter Kindergarten or first grade for the first time before July 1, 2015.

(9) Pneumococcal conjugate vaccine – Four doses; 3 doses by age 7 months and a booster dose at 12

through 15 months of age. However:

(A) Individuals who receive the first dose of pneumococcal conjugate vaccine on or after 7

months of age and before 12 months of age are required to have 2 doses at least 4 weeks

apart; and a booster dose at 12 through 15 months of age.

(B) Individuals who receive the first dose of pneumococcal conjugate vaccine on or after 12

months of age and before 24 months of age are required to have 2 doses at least 8 weeks

apart to complete the series.

(C) Individuals who receive the first dose of pneumococcal conjugate vaccine on or after 24

months of age and before 5 years are required to have 1 dose to complete the series.

(D) No individual who has passed his or her fifth birthday shall be required to be vaccinated

against pneumococcal disease.

(E) An individual born before July 1, 2015 shall not be required to receive pneumococcal

conjugate vaccine.

(10) Meningococcal conjugate vaccine – two doses: one dose is required for individuals entering the

seventh grade or by 12 years of age, whichever comes first, on or after July 1, 2015. A booster dose is

required by 17 years of age or by entering the 12th grade. However:

(A) The first dose does not apply to individuals who entered seventh grade before July 1, 2015.

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(B) The booster dose does not apply to individuals who entered the 12th grade before August 1,

2020.

(C) If the first dose is administered on or after the 16th birthday, a booster dose is not required.

(D) An individual born before January 1, 2003 shall not be required to receive a meningococcal

conjugate vaccine.

(b) The healthcare provider shall administer immunizations in accordance with this Rule. However, if a healthcare

provider administers vaccine up to and including the fourth day prior to the required minimum age, the individual dose is

not required to be repeated. Doses administered more than four days prior to the requirements are considered invalid

doses and shall be repeated.

(c) The State Health Director may suspend temporarily any portion of the requirements of this Rule due to emergency

conditions, such as the unavailability of vaccine. The Department shall give notice in writing to all local health

departments and other providers currently receiving vaccine from the Department when the suspension takes effect and

when the suspension is lifted. When any vaccine series is disrupted by such a suspension, the next dose shall be

administered within 90 days of the lifting of the suspension and the series resumed in accordance with intervals

determined by the most recent recommendations of the Advisory Committee on Immunization Practices. These

recommendations may be accessed free of charge at http://www.cdc.gov/vaccines/acip/.

History Note: Authority G.S. 130A-152(c); 130A-155.1;

Eff. February 1, 1976;

Amended Eff. July 1, 1977;

Readopted Eff. December 5, 1977;

Temporary Amendment Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Amended Eff. October 1, 1995; October 1, 1994; January 1, 1994; January 4, 1993;

Temporary Amendment Eff. February 23, 2000; August 20, 1999; May 21, 1999;

Amended Eff. August 1, 2000;

Temporary Amendment Eff. May 17, 2002; April 1, 2002; February 18, 2002; August 1, 2001;

Amended Eff. July 1, 2015; January 1, 2008; November 1, 2005; January 1, 2005; April 1, 2003.

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10A NCAC 41A .0402 APPROVED VACCINE PREPARATIONS

All vaccine preparations licensed for interstate use by the Bureau of Biologic Standards of the U.S. Food and Drug

Administration are approved for use in fulfilling the requirements of 10 NCAC 07A .0401.

History Note: Authority G.S. 130A-152(c);

Eff. February 1, 1976;

Readopted Eff. December 5, 1977.

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10A NCAC 41A .0403 NON-RELIGIOUS PERSONAL BELIEF NO EXEMPTION

Except as provided in G.S. 130A-156 and G.S. 130A-157, and 10A NCAC 41A .0404 and .0405, no child shall be exempt

from the requirements of 10A NCAC 41 .0401; there is no exception to these requirements for the case of a personal belief or

philosophy of a parent or guardian not founded upon a religious belief.

History Note: Authority G.S. 130A-152(c);

Eff. February 1, 1976;

Readopted Eff. December 5, 1977;

Amended Eff. October 1, 1984; July 1, 1979.

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10A NCAC 41A .0404 MEDICAL EXEMPTIONS FROM IMMUNIZATION

(a) Certification of a medical exemption by a physician pursuant to G.S. 130A-156 shall be in writing and shall state the

basis of the exemption, the specific vaccine or vaccines the individual should not receive, and the length of time the

exemption will apply for the individual.

(b) Medical contraindications for which medical exemptions may be certified by a physician for immunizations are

included in the most recent General Recommendations of the Advisory Committee on Immunization Practices, Public

Health Services, U.S. Department of Health and Human Services, published in the Centers for Disease Control and

Prevention publication, the Morbidity and Mortality Weekly Report, which is adopted by reference including subsequent

amendments and additions. A copy is available for inspection in the Immunization Section at 1330 St. Mary's Street,

Raleigh, North Carolina. Internet access is available by searching www.cdc.gov/nip.

History Note: Filed as a Temporary Amendment Eff. February 1, 1988, for a period of 180 days to expire on July

29, 1988;

Authority G.S. 130A-152(c); 130A-156;

Eff. July 1, 1979;

Amended Eff. August 1, 2000; January 4, 1993; February 1, 1990; March 1, 1988.

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10A NCAC 41A .0405 EXEMPTION FOR CLINICAL STUDIES

An individual enrolled in a clinical trial of the efficacy of a new vaccine preparation or dosage schedule shall be exempted

from those requirements of 10A NCAC 41A .0401 and .0402 which conflict with the trial protocol. This exemption shall only

apply to individuals who:

(1) participate in a clinical trial whose protocol is approved by the State Health Director, and

(2) fully participate in and complete the clinical trial.

History Note: Filed as a Temporary Amendment Eff. February 1, 1988, for a period of 180 days to expire on

July 29, 1988;

Authority G.S. 130A-152(c);

Eff. October 1, 1983;

Amended Eff. March 1, 1988.

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10A NCAC 41A .0406 ACCESS TO IMMUNIZATION INFORMATION

(a) Physicians, local health departments and the Department shall, upon request and without consent release the

immunization information specified in Paragraph (b) of this Rule to the following organizations:

(1) schools K-12, whether public, private or religious;

(2) licensed and registered childcare facilities as defined in G.S. 110-86(3) and G.S. 110-101;

(3) Head Start;

(4) colleges and universities, whether public, private or religious;

(5) Health Maintenance Organizations; and

(6) Other state and local health departments outside of North Carolina.

(b) The following is the immunization information to be released to the organizations specified in Paragraph (a) of this

Rule:

(1) name and address;

(2) name of the parent, guardian, or person standing in loco parentis;

(3) date of birth;

(4) gender;

(5) race and ethnicity;

(6) vaccine type, date and dose number administered;

(7) the name and address of the physician or local health department that administered each dose; and

(8) the existence of a medical or religious exemption determined by the Immunization Section to meet the

requirements of G.S. 130A-156 and 10A NCAC 41A .0404 or G.S. 130A-157. If such a determination

has not been made by the Division of Public Health, the person shall have access to the certification of

medical and religious exemptions required by G.S. 130A-156 or G.S. 130A-157 and 10A NCAC 41A

.0404.

History Note: Authority G.S. 130A-153;

Temporary Adoption Eff. August 9, 1993, for a period of 180 days or until the permanent rule

becomes effective, whichever is sooner;

Eff. January 4, 1994;

Amended Eff. April 1, 2001; August 1, 2000; October 1, 1995.